Vaccine Process Associate

at  WuXi Biologics

REQUIREMENTS:

• A keen interest and desire to develop a career in the pharma industry.
• Experience working as part of a team.
• Experience with recording information in real time using electronic or manual systems.
• Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems desirable
• Experience in biopharmaceutical industry is an advantage.
• Experience of working in Grade CNC, C and D environment is an advantage.
• Involvement working in a fast-paced green field project would be an advantage.
• Certificate, Diploma, Degree, Trade qualification or equivalent demonstrated experience of 12 months or more experience in a regulated environment.

OTHER SKILLS, ABILITIES & EXPERIENCE:

• Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills
• An ability to work independently, and as a member of a self - managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative.

OTHER INFORMATION:

• The role will be shift working.
• Due to the start-up nature of the project, there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description.

• Perform all core production activities in DP facility
• Manufacturing processes include Formulation of Buffer, Stabilizer and Drug Product Filling, Capping and Inspection
• Support the development, commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.
• Assist in maintaining a safety orientated Culture, cGMP compliant work environment always
• Responsible for completion of manufacturing tasks according to SOPs and batch records (paper and electronic).
• Perform initial troubleshooting of issues identified during routine operations.
• Assist with the investigation of manufacturing deviations through Quality System, engaging with all relevant personnel and functions as appropriate.
• Write, review, revise and approve of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions
• Training and mentoring of colleagues in SOPs, process execution and equipment operation.
• Seek opportunities for Continuous Improvement using Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, etc.)
• Where necessary assist in any in Facility and Equipment start up and Validation activities.
• Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
• Capable of working with individuals and with a team of up to 20 people
• Provide technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team e.g. Environmental Monitoring, Lean, etc.
• Provide manufacturing status update during shift handovers
• Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
• Conduct all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.